The Relationship Between VDR Gene Polymorphism and Children's Physical and Intellectual Development (RVDRGPCPID)

Multi-Center Clinical Study on the Relationship Between Vitamin D Receptor Gene Polymorphism and Children's Physical and Intellectual Development

This study was used to determine the relationship between vitamin D receptor gene polymorphism and children's physical and intellectual development, further adjust the doses of vitamin D supplementation after birth, and provide individualized vitamin D and calcium supplements.

Study Overview

• Status: Unknown
• Conditions: Development, Child
• Intervention / Treatment: Drug: Vitamin D

Detailed Description

High risk children aged 0-3 years old who visited the pediatrics clinic and ward of the first affiliated hospital of Xi'an Jiaotong university and other cooperative hospitals from 2018 to 2020 were randomly selected. Personal information of the children and parents who were enrollment was collected by questionnaire survey and a follow-up file was established. 500 to 1,000 people are planned to participate in the study, were randomly divided into research group and the control group. Then collect the sample(saliva) of children to examine Vitamin D Receptor(VDR) genotype, according to results, divide the research group into high, medium and low risk, given individual vitamin D and calcium supplement. Monitor the children's weight, body length, head circumference, the Neonatal Behavioral Assessment Scale(NBAS), bailey rating scale respectively, up to 3 years old. All sample analyses were performed by the Gene Medical Laboratory. Laboratory personnel were blinded to mother and infant outcomes.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Li, PHD,MD; Phone Number: +8618991232133; Email: huili@mail.xjtu.edu.cn
• Study Contact Backup: Name: Zhongliang Zhu, PHD; Phone Number: +8613991289992; Email: zlzhu@mail.xjtu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Hui A Li, PhD, MD; Phone Number: +8618991232133; Email: huili@mail.xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• infant age from 0 to 3 years old
• enjoy good health, there is no history of specific diseases

Exclusion Criteria:

• this time or always exists serious lung infection, or with nervous system disease, kidney disease, malignant tumor, etc
• has bone metabolic diseases or other genetic metabolic disease
• taking affect bone metabolism of drugs for a long time

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: identical supplement group; Take vitamin D supplements according to genotype. If the genotype result is "high risk", we will give vitamin d 800 international unit(IU)/d, when the result is "middle risk", we will give 600 international unit(IU)/d, when the result is "low risk", we will give 400 international unit(IU)/d.	Drug: Vitamin D; Vitamin D is essential for healthy bones, and to control the amount of calcium in our blood.It is important at every stage of life, but especially for rapidly growing infants and teenagers and for pregnant and breastfeeding women.; Other Names: calcitriol
No Intervention: control group; General dose. Whatever the result is, we all give 400 international unit(IU)/d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	We will use the baby scale to measure infant body weight	From date of randomization until the date of three year-old
body height	We will use the baby scale to measure infant body height	From date of randomization until the date of three year-old
head circumference	We will use the tape to measure infant head circumference	From date of randomization until the date of three year-old

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: The First Affiliated Hospital of Zhengzhou University; Xian Children's Hospital
• Investigators: Study Chair: Hui Li, PHD,MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Vitamin D Receptor gene; physical development; intelligent development
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Vitamin D; Calcitriol
• Other Study ID Numbers: HX201856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No